Container-/Closure-Integrity Testing - Online Training Recording
Course No. 22718
Speakers
Roland Koch
Gasporox
Christof Langer
OSConsulting
Jens Höllein
be integral
Target Group
This conference is directed at specialists and executives from the areas engineering and production and QA dealing with the implementation and operation of systems for the container/closure-integrity testing of sterile medicinal products.
Objectives
Different products and different container types require different testing methods: this event aims at giving an overview of the different CCI testing systems which are applied during production and as part of the quality control system. Apart from technical aspects the regulatory requirements on CCI testing will be highlighted as well as the applicability of inline and offline testing.
Background
An intact container closure system, which is the sum of packaging components that protect the dosage form, is the pre-requisite for a safe and sterile drug product. The CC system protects the product from microbial contamination and also from exposure to gases or water vapour or the loss of solvent. Container Closure integrity testing is therefore a regulatory requirement and it is part of the whole life cycle of a sterile drug product.
Initially this testing was performed as part of the initial Development of the packaging system and the system’s suitability verified in stability studies including on-going stability. Over the years, the expectation was raised to perform batch by Batch verification with latest trends to 100% inline or offline testing wherever possible. We will discuss and answer questions like:
What are the current and upcoming GMP- and compendial requirements in the US / EU / RoW?
Will container closure integrity testing change to 100% inline testing?
What does the Annex 1 require?
How do we have to define ’tight’?
How to set up and defend a CCI control strategy
Which testing technologies are available and suitable?
CCI testing of vials
Programme
Container Closure Integrity Testing of Sterile Drug Products – Requirements, Expectations and Exaggerations
Container Closure Integrity during development, qualification and stability testing
Regulatory, Pharmacopoeial and GMP requirements
System integrity versus container damages
Patient risks – do we need batch by batch testing?
Industrial best practices
Overview of Container-/Closure-Integrity Testing Technologies The presentation gives a complete overview of the different aspects of leak testing to do CCIT in the pharmaceutical production. The systems presented can be used for the CCIT of vials, ampoules, syringes, BFS, IV bags, blisters etc.
Leak, leak rate and the relevant physical Units
Leak test Methods
Pressure change methods (vacuum, pressure and LFC)
Head Space Analysis using TDLAS
Helium Leak Test and other Mass Spectroscopy Systems
High Voltage Leak Detection (HVLD)
Force Sensing Technology
Capabilities and examples of the different methods
How to select the right method
How to generate positive controls
Leak Testing: Concept and Implementation at Boehringer Ingelheim
Overall CCIT concept at the Ingelheim site
Standard leak: production, areas of application
Differentiation between the basic test methods (probabilistic vs. deterministic; inline vs. offline, etc.)
Tests at the Ingelheim site (from bubble test to microbiological tests to headspace analysis)
Qualification strategy for vacuum decay testing
Hidden Defects in CCIT and their effects on Stability and Sterility
The formation of defects that affect stability
Detection of hidden defects
Clogging
FDA & CCIT in Lieu of Sterility
Hidden defects with possible effect on sterility
Residual Seal Force (RSF) & Headspace (HSA) Testing of Vials
Setup of the testing System
Usage of HAS in product Validation
Statistical control by sampling RSF
Further Information
Technical Details To participate in an on demand training course or webinar, you do not need any software. The recordings are made available via a streaming server. In general, the recording is provided in MP4 format, which any PC (Microsoft Windows, Apple IOS) or tablet can easily Display.
Timing and Duration When you register for the on demand Training course or webinar you can decide at what date you want to follow the training course online. For a 1-day training course you will have 2 days in which the stream is available (for 2-day training course 3 days and for a 3-day training course 4 days). Within in this timeframe you can start & stop the stream according to your needs.
In time before the scheduled date (your desired date) you will receive an e-mail from us with a link for direct participation as well as your log-in data.
Please be aware: The recording does not include the Q & A sessions.
Training Course Documentation and Certificate The presentations will be made available as PDF files via download shortly before the online training course. After the event, you will automatically receive your certificate of participation.
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